NCT07142057

Brief Summary

To evaluate the impact of the 23-valent pneumonia vaccine on the incidence of pulmonary infection and survival in lung cancer patients, and to explore its preventive effect and safety in the lung cancer patients.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
51mo left

Started Sep 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Sep 2025Sep 2030

First Submitted

Initial submission to the registry

August 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

August 19, 2025

Last Update Submit

August 19, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • The incidence of pneumonia at 12 months

    During the 12-month follow-up period, the incidence of pulmonary infection in lung cancer patients was evaluated through regular clinical examinations, imaging tests, and laboratory tests.

    12 months

  • Incidence of pneumonia

    The proportion of lung cancer patients who developed pneumonia during the study period.

    24 months

Secondary Outcomes (1)

  • Survival rate

    5 years

Other Outcomes (7)

  • Lung cancer-related complications

    5 years

  • Length of hospital stay

    5 years

  • Hospitalization rate

    5 years

  • +4 more other outcomes

Study Arms (2)

Vaccination group

Lung cancer patients receive 23-valent pneumonia vaccine

Biological: 23-valent pneumococcal vaccine

Unvaccinated group

Lung cancer patients have not received the 23-valent pneumococcal vaccine

Interventions

Receive the 23-valent pneumococcal vaccine; Do not receive the 23-valent pneumococcal vaccine

Vaccination group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lung cancer patients can receive or not receive the 23-valent pneumococcal vaccine

You may qualify if:

  • Male or female patients \>=18 years of age;
  • Histological diagnosis of NSCLC, including both non-small cell lung cancer and small cell lung cancer, regardless of whether they are in the early, locally advanced stage or advanced stage, and regardless of whether they have received surgery, radiotherapy, chemotherapy or other treatments;
  • Never received pneumococcal vaccine

You may not qualify if:

  • Patients having other factors that preventing researchers from enrollment them.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Neoplasms

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The First Affiliated Hospital of Guangzhou Medical University

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 26, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2030

Last Updated

August 26, 2025

Record last verified: 2025-08